Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Systemic and regional hemodynamics
研究概览
简要总结
The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.
详细描述
Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Septic shock
- •vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)
排除标准
- •Pregnancy
- •Present cardiac dysfunction
- •Present or suspected acute mesenteric ischemia
研究组 & 干预措施
1
Terlipressin
干预措施: Terlipressin (Drug)
2
Vasopressin
干预措施: Vasopressin (Drug)
3
titrated norepinephrine
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Systemic and regional hemodynamics
时间窗: during the first 48 hours from the onset of septic shock
次要结局
- Markers of inflammation,organ functions,adverse effects.(during the first 48 hours from the onset of septic shock)